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Botox for the Treatment of Chronic Exertional Compartment Syndrome

OnabotulinumtoxinA (Botox) Effect on Pain and Return to Sport in Chronic Exertional Compartment Syndrome of the Anterior Leg: A Pilot Study

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03922139
Enrollment
7
Registered
2019-04-19
Start date
2019-10-08
Completion date
2021-12-15
Last updated
2023-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compartment Syndrome of Leg

Brief summary

After diagnosis of Chronic Exertional Compartment Syndrome (CECS), the participants will be referred to both physical therapy and Botox injection. In physical therapy, the therapist will perform strength measurements of the lower leg (ankle plantarflexion and dorsiflexion) which will be repeated 2 months following the injection. An ultrasound-guided injection of 50 units of Botox will be administered into the tibialis anterior. 25 units will be injected into two different spots in the muscle one being more proximal and the other distal. This will be a one-time injection and will be observed as to how it effects participant symptoms over the next 6 months at either a clinic visit (at 2 months) or telephone call (at 4 and 6 months after injection) via the University of Wisconsin Running Index. Two months following the injection, the participant will undergo repeat measurements of strength using the Kiio Force Sensor. Should potential participants of childbearing potential wish to enroll in the study, a urine pregnancy test will be performed prior to enrollment; participants will not be enrolled if test is positive.

Detailed description

Chronic exertional compartment syndrome (CECS) is an overuse injury first described by Mavor in 1956 that typically affects young endurance athletes, classically distance runners. CECS occurs primarily in the lower leg, predominantly in the anterior compartment, although it has been reported elsewhere in the body. The pathophysiology of CECS is not completely understood. Similar to acute compartment syndrome, it is thought to result from increased pressure within the restrictions of the fascial planes of a muscle compartment. Exercise increases blood flow to active muscles causing them to expand. If constricted by surrounding noncompliant fascia, such swelling increases pressure within the muscle compartment. Ultimately, pressure within the compartment reduces blood flow leading to muscle ischemia and pain when metabolic demands cannot be met. Several studies have demonstrated decreased blood flow and oxygenation in the legs of symptomatic patients with CECS. Cessation of inciting activities resolves symptoms in most cases of CECS. Without this cessation, the prognosis for CECS is poor if treated non-operatively. Should symptoms continue, patients are referred for possible muscle compartment release, currently the most widely accepted treatment approach despite a significant number of treatment failures. To date, no alternative non-operative approach has successfully treated refractory symptoms. Recently, it has been hypothesized that botulinum toxin could reduce intramuscular pressure in CECS . Isner-Horoboti et al, performed abobotulinum toxin A injections into the anterior and anterior/lateral compartments in 16 individuals with a mean follow up of 4.4 months (range 3-6 months). Fifteen (95%) patients were asymptomatic after intervention with fourteen (88%) exhibiting normalized post-exercise compartment pressures. Using manual muscle testing, they determined that 11 patients displayed decreased strength though did not produce noticeable subjective weakness. A later case report by Baria and Sellon presented the first long-term follow up (14 months) of a CECS case treated with botulinum toxin injections (Botox) in which the patient reported continued pain relief and had resumed her active lifestyle without adverse effects. The proposed investigation will aim to build upon the results of existing studies. The novelty of this approach involves a differing dosage of the toxin (Botox) into a more targeted muscle group, specifically the tibialis anterior, while also utilizing a smaller dosage than in previous studies. Further, while previous studies have used manual muscle testing to test strength, many studies have found this method unreliable. As such, a Kiio force sensor will be used at multiple time points to determine weakness quantitatively. Lastly, the reliable and validated University of Wisconsin Running Index will be used to evaluate return to sport. After diagnosis of CECS, the participants will be referred to both physical therapy and Botox injection. In physical therapy, the therapist will perform strength measurements of the lower leg (ankle plantarflexion and dorsiflexion) which will be repeated 2 months following the injection. An ultrasound-guided injection of 50 units of Botox into the tibialis anterior will be performed. 25 units will be injected into two different spots in the muscle, one being more proximal and the other distal. This will be a one-time injection that will be monitored to see how it effects participant symptoms over the next 6 months at either a clinic visit (at 2 months) or telephone call (at 4 and 6 months after injection) via the University of Wisconsin Running Index. Two months following the injection, the participant will undergo repeat measurements of strength using the Kiio Force Sensor. Should potential participants be of childbearing potential wish to enroll in the study, a urine pregnancy test will be performed prior to enrollment; participants will not be enrolled if test is positive.

Interventions

Ultrasound guided 1 mg/1 mL injection. 25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Willing to provide written informed consent * Willing to comply with all study procedures and be available for the duration of the study including reliable use of telephone for communication * Male or female, at least 18 years of age * Documented diagnosis of CECS * Females of childbearing potential must have a negative urine pregnancy test prior to enrollment and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to enrollment and for the duration of study participation. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). * Be involved, either competitively or non-competitively, in an activity requiring significant running as determined by the PI

Exclusion criteria

* History of hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes * Known neuromuscular disease * Known pulmonary disease including but not limited to asthma, pneumonia, or upper respiratory tract infection * Dysphagia * Known cardiac disease including but not limited to congestive heart failure, arrhythmia, or history of myocardial infarction * History of lower extremity fasciotomy * Enrolled in another clinical trial or has used any investigational drugs, biologics, or devices within 30 days prior to enrollment * Currently or have taken in the past medications that affect neuromuscular function: aminoglycosides, muscle relaxants, or other botulinum neurotoxin agents * Women who are pregnant or breast-feeding * Vulnerable populations * Not suitable for study participation due to other reasons at the discretion of the investigator

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Relief of PainBaseline, 2 months, 4 months and 6 monthsPercentage of Relief of Pain will be assessed at each time point (2,4,6 months) using Friedman's ANOVA.
Number of Participants With Lower Extremity Weaknessup to 6 monthsA primary safety endpoint is the incidence of lower extremity weakness
Incidence of Adverse Eventsup to 6 monthsA primary safety endpoint is the incidence of adverse events, such as bruising, bleeding, pain, redness, or swelling where the injection was given.

Secondary

MeasureTime frameDescription
Change in Ankle Eversion Strength Using Kiio Force Sensorbaseline and month 2A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs).
Change in Ability to Perform Activities of Daily Livingbaseline, 2 months, 4 months, 6 monthsA question on the UWRI asks the participant to indicate how their running injury impacts their ability to perform daily activities: No Impact, Slightly Impact, Moderately Impact, Significantly Impact, Unable to Perform.
Participant Frustration With Injurybaseline, 2 months, 4 months, 6 monthsA question on the UWRI asks the participant to indicate how frustrated they are by their running injury: Not frustrated, Mildly frustrated, Moderately frustrated, Significantly frustrated, or Extremely frustrated.
Participant Perception of Recovery From Injurybaseline, 2 months, 4 months, 6 monthsA question on the UWRI asks the participant to indicate how much recovery have they made from their running injury: Complete Recovery, Significant Recovery, Moderate Recovery, Minimal Recovery, No Recovery.
Change in Ankle Dorisflexsion Strength Using Kiio Force Sensorbaseline and month 2A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs).
Change in Running Duration: Weeklybaseline, 2 months, 4 months, 6 monthsA question on the UWRI asks the participant to indicate if their weekly mileage or weekly running time changed as a result of their injury: Same or greater than before injury, Minimally reduced, Moderately reduced, Significantly reduced, Unable to Run.
Change in Running Duration: Longest Runbaseline, 2 months, 4 months, 6 monthsA question on the UWRI asks the participant to indicate if the distance of their longest weekly run has changed as a result of their injury: Same or longer than before my injury, Minimally reduced, Moderately reduced, Significantly reduced, Unable to Run.
Change in Running Speedbaseline, 2 months, 4 months, 6 monthsA question on the UWRI asks the participant to indicate if the distance of the longest weekly run has changed as a result of their injury: Same or faster than before my injury, Minimally reduced, Moderately reduced, Significantly reduced, Unable to Run.
Participant Confidence in Increasing the Duration and Intensity of Runningbaseline, 2 months, 4 months, 6 monthsA question on the UWRI asks the participant to indicate how their injury affects their confidence to increase the duration or intensity of their running: Confident to increase my running, If I increase I might be fine, Neutral, If I increase I might get worse, I cannot increase my running.
Pain in the 24 Hours Following Runningbaseline, 2 months, 4 months, 6 monthsA question on the UWRI asks the participant to indicate how much pain they experience during the 24 hours following a run: No pain, Minimal pain, Moderate pain, Significant pain, Unable to Run.
Change in Ankle Plantarflexion Strength Using Kiio Force Sensorbaseline and month 2A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs).
Change in Ankle Inversion Strength Using Kiio Force Sensorbaseline and month 2A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs).

Countries

United States

Participant flow

Recruitment details

Participants were recruited at the University of Wisconsin - Madison from October 2019 to February 2021.

Participants by arm

ArmCount
Botox
Ultrasound guided 1 mg/1 mL injection. 25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle. OnabotulinumtoxinA Injection: Ultrasound guided 1 mg/1 mL injection. 25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.
7
Total7

Baseline characteristics

CharacteristicBotox
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
6 Participants
Region of Enrollment
United States
7 participants
Sex/Gender, Customized
Female
4 Participants
Sex/Gender, Customized
Male
3 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 7
other
Total, other adverse events
0 / 7
serious
Total, serious adverse events
0 / 7

Outcome results

Primary

Incidence of Adverse Events

A primary safety endpoint is the incidence of adverse events, such as bruising, bleeding, pain, redness, or swelling where the injection was given.

Time frame: up to 6 months

ArmMeasureValue (NUMBER)
BotoxIncidence of Adverse Events0 number of adverse events
Primary

Number of Participants With Lower Extremity Weakness

A primary safety endpoint is the incidence of lower extremity weakness

Time frame: up to 6 months

Population: one participant dropped from the study

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BotoxNumber of Participants With Lower Extremity Weakness0 Participants
Primary

Percentage of Relief of Pain

Percentage of Relief of Pain will be assessed at each time point (2,4,6 months) using Friedman's ANOVA.

Time frame: Baseline, 2 months, 4 months and 6 months

Population: not all participants completed the assessment for all time points

ArmMeasureGroupValue (MEAN)
BotoxPercentage of Relief of PainBaseline0 percentage relief of pain
BotoxPercentage of Relief of Pain2 months80.7 percentage relief of pain
BotoxPercentage of Relief of Pain4 months100 percentage relief of pain
BotoxPercentage of Relief of Pain6 months100 percentage relief of pain
Secondary

Change in Ability to Perform Activities of Daily Living

A question on the UWRI asks the participant to indicate how their running injury impacts their ability to perform daily activities: No Impact, Slightly Impact, Moderately Impact, Significantly Impact, Unable to Perform.

Time frame: baseline, 2 months, 4 months, 6 months

Population: One participant did not answer the 4 month survey

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
BotoxChange in Ability to Perform Activities of Daily LivingbaselineNo Impact2 Participants
BotoxChange in Ability to Perform Activities of Daily LivingbaselineSlightly Impact0 Participants
BotoxChange in Ability to Perform Activities of Daily LivingbaselineModerately Impact2 Participants
BotoxChange in Ability to Perform Activities of Daily LivingbaselineSignificantly Impact3 Participants
BotoxChange in Ability to Perform Activities of Daily LivingbaselineUnable to Perform0 Participants
BotoxChange in Ability to Perform Activities of Daily Living2 monthsNo Impact4 Participants
BotoxChange in Ability to Perform Activities of Daily Living2 monthsSlightly Impact3 Participants
BotoxChange in Ability to Perform Activities of Daily Living2 monthsModerately Impact0 Participants
BotoxChange in Ability to Perform Activities of Daily Living2 monthsSignificantly Impact0 Participants
BotoxChange in Ability to Perform Activities of Daily Living2 monthsUnable to Perform0 Participants
BotoxChange in Ability to Perform Activities of Daily Living4 monthsNo Impact6 Participants
BotoxChange in Ability to Perform Activities of Daily Living4 monthsSlightly Impact0 Participants
BotoxChange in Ability to Perform Activities of Daily Living4 monthsModerately Impact0 Participants
BotoxChange in Ability to Perform Activities of Daily Living4 monthsSignificantly Impact0 Participants
BotoxChange in Ability to Perform Activities of Daily Living4 monthsUnable to Perform0 Participants
BotoxChange in Ability to Perform Activities of Daily Living6 monthsNo Impact7 Participants
BotoxChange in Ability to Perform Activities of Daily Living6 monthsSlightly Impact0 Participants
BotoxChange in Ability to Perform Activities of Daily Living6 monthsModerately Impact0 Participants
BotoxChange in Ability to Perform Activities of Daily Living6 monthsSignificantly Impact0 Participants
BotoxChange in Ability to Perform Activities of Daily Living6 monthsUnable to Perform0 Participants
Secondary

Change in Ankle Dorisflexsion Strength Using Kiio Force Sensor

A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs).

Time frame: baseline and month 2

Population: one participant did not return for 2 month measures

ArmMeasureGroupValue (MEAN)
BotoxChange in Ankle Dorisflexsion Strength Using Kiio Force Sensorbaseline left ankle24.6 degrees
BotoxChange in Ankle Dorisflexsion Strength Using Kiio Force Sensorbaseline right ankle24.6 degrees
BotoxChange in Ankle Dorisflexsion Strength Using Kiio Force Sensor2 months left ankle25.2 degrees
BotoxChange in Ankle Dorisflexsion Strength Using Kiio Force Sensor2 months right ankle25.0 degrees
Secondary

Change in Ankle Eversion Strength Using Kiio Force Sensor

A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs).

Time frame: baseline and month 2

Population: one participant did not return for 2 month measures

ArmMeasureGroupValue (MEAN)
BotoxChange in Ankle Eversion Strength Using Kiio Force Sensorbaseline left ankle22.8 degrees
BotoxChange in Ankle Eversion Strength Using Kiio Force Sensorbaseline right ankle22.7 degrees
BotoxChange in Ankle Eversion Strength Using Kiio Force Sensor2 months left ankle23.3 degrees
BotoxChange in Ankle Eversion Strength Using Kiio Force Sensor2 months right ankle23.3 degrees
Secondary

Change in Ankle Inversion Strength Using Kiio Force Sensor

A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs).

Time frame: baseline and month 2

Population: one participant did not return for 2 month measures

ArmMeasureGroupValue (MEAN)
BotoxChange in Ankle Inversion Strength Using Kiio Force SensorBaseline left ankle22.4 degrees
BotoxChange in Ankle Inversion Strength Using Kiio Force Sensorbaseline right ankle22.6 degrees
BotoxChange in Ankle Inversion Strength Using Kiio Force Sensor2 months left ankle22.9 degrees
BotoxChange in Ankle Inversion Strength Using Kiio Force Sensor2 months right ankle23.1 degrees
Secondary

Change in Ankle Plantarflexion Strength Using Kiio Force Sensor

A Kiio Force Sensor will be used to measure the change in ankle strength. Change in strength outcomes at baseline and 2 months will be assessed using Wilcoxon signed rank tests or, if necessary, linear mixed effects models for repeated measures, to account for intra-subject correlation (left and right legs).

Time frame: baseline and month 2

Population: one participant did not return for 2 month measures

ArmMeasureGroupValue (MEAN)
BotoxChange in Ankle Plantarflexion Strength Using Kiio Force Sensorbaseline left ankle172.5 degrees
BotoxChange in Ankle Plantarflexion Strength Using Kiio Force Sensorbaseline right ankle173.8 degrees
BotoxChange in Ankle Plantarflexion Strength Using Kiio Force Sensor2 months left ankle176.5 degrees
BotoxChange in Ankle Plantarflexion Strength Using Kiio Force Sensor2 months right ankle177.0 degrees
Secondary

Change in Running Duration: Longest Run

A question on the UWRI asks the participant to indicate if the distance of their longest weekly run has changed as a result of their injury: Same or longer than before my injury, Minimally reduced, Moderately reduced, Significantly reduced, Unable to Run.

Time frame: baseline, 2 months, 4 months, 6 months

Population: One participant did not complete the 4 month survey.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
BotoxChange in Running Duration: Longest RunbaselineSame or longer than before my injury1 Participants
BotoxChange in Running Duration: Longest RunbaselineMinimally reduced0 Participants
BotoxChange in Running Duration: Longest RunbaselineModerately reduced2 Participants
BotoxChange in Running Duration: Longest RunbaselineSignificantly reduced4 Participants
BotoxChange in Running Duration: Longest RunbaselineUnable to Run0 Participants
BotoxChange in Running Duration: Longest Run2 monthsSame or longer than before my injury6 Participants
BotoxChange in Running Duration: Longest Run2 monthsMinimally reduced1 Participants
BotoxChange in Running Duration: Longest Run2 monthsModerately reduced0 Participants
BotoxChange in Running Duration: Longest Run2 monthsSignificantly reduced0 Participants
BotoxChange in Running Duration: Longest Run2 monthsUnable to Run0 Participants
BotoxChange in Running Duration: Longest Run4 monthsSame or longer than before my injury6 Participants
BotoxChange in Running Duration: Longest Run4 monthsMinimally reduced0 Participants
BotoxChange in Running Duration: Longest Run4 monthsModerately reduced0 Participants
BotoxChange in Running Duration: Longest Run4 monthsSignificantly reduced0 Participants
BotoxChange in Running Duration: Longest Run4 monthsUnable to Run0 Participants
BotoxChange in Running Duration: Longest Run6 monthsSame or longer than before my injury7 Participants
BotoxChange in Running Duration: Longest Run6 monthsMinimally reduced0 Participants
BotoxChange in Running Duration: Longest Run6 monthsModerately reduced0 Participants
BotoxChange in Running Duration: Longest Run6 monthsSignificantly reduced0 Participants
BotoxChange in Running Duration: Longest Run6 monthsUnable to Run0 Participants
Secondary

Change in Running Duration: Weekly

A question on the UWRI asks the participant to indicate if their weekly mileage or weekly running time changed as a result of their injury: Same or greater than before injury, Minimally reduced, Moderately reduced, Significantly reduced, Unable to Run.

Time frame: baseline, 2 months, 4 months, 6 months

Population: One participant did not complete the 4 month survey.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
BotoxChange in Running Duration: WeeklybaselineSame or greater than before injury0 Participants
BotoxChange in Running Duration: WeeklybaselineMinimally reduced0 Participants
BotoxChange in Running Duration: WeeklybaselineModerately reduced2 Participants
BotoxChange in Running Duration: WeeklybaselineSignificantly reduced3 Participants
BotoxChange in Running Duration: WeeklybaselineUnable to Run2 Participants
BotoxChange in Running Duration: Weekly2 monthsSame or greater than before injury6 Participants
BotoxChange in Running Duration: Weekly2 monthsMinimally reduced1 Participants
BotoxChange in Running Duration: Weekly2 monthsModerately reduced0 Participants
BotoxChange in Running Duration: Weekly2 monthsSignificantly reduced0 Participants
BotoxChange in Running Duration: Weekly2 monthsUnable to Run0 Participants
BotoxChange in Running Duration: Weekly4 monthsSame or greater than before injury6 Participants
BotoxChange in Running Duration: Weekly4 monthsMinimally reduced0 Participants
BotoxChange in Running Duration: Weekly4 monthsModerately reduced0 Participants
BotoxChange in Running Duration: Weekly4 monthsSignificantly reduced0 Participants
BotoxChange in Running Duration: Weekly4 monthsUnable to Run0 Participants
BotoxChange in Running Duration: Weekly6 monthsSame or greater than before injury7 Participants
BotoxChange in Running Duration: Weekly6 monthsMinimally reduced0 Participants
BotoxChange in Running Duration: Weekly6 monthsModerately reduced0 Participants
BotoxChange in Running Duration: Weekly6 monthsSignificantly reduced0 Participants
BotoxChange in Running Duration: Weekly6 monthsUnable to Run0 Participants
Secondary

Change in Running Speed

A question on the UWRI asks the participant to indicate if the distance of the longest weekly run has changed as a result of their injury: Same or faster than before my injury, Minimally reduced, Moderately reduced, Significantly reduced, Unable to Run.

Time frame: baseline, 2 months, 4 months, 6 months

Population: One participant did not complete the 4 month survey.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
BotoxChange in Running SpeedbaselineMinimally reduced2 Participants
BotoxChange in Running SpeedbaselineSame or faster than before my injury0 Participants
BotoxChange in Running SpeedbaselineModerately reduced1 Participants
BotoxChange in Running SpeedbaselineSignificantly reduced2 Participants
BotoxChange in Running SpeedbaselineUnable to Run2 Participants
BotoxChange in Running Speed2 monthsSame or faster than before my injury7 Participants
BotoxChange in Running Speed2 monthsMinimally reduced0 Participants
BotoxChange in Running Speed2 monthsModerately reduced0 Participants
BotoxChange in Running Speed2 monthsSignificantly reduced0 Participants
BotoxChange in Running Speed2 monthsUnable to Run0 Participants
BotoxChange in Running Speed4 monthsSame or faster than before my injury6 Participants
BotoxChange in Running Speed4 monthsMinimally reduced0 Participants
BotoxChange in Running Speed4 monthsModerately reduced0 Participants
BotoxChange in Running Speed4 monthsSignificantly reduced0 Participants
BotoxChange in Running Speed4 monthsUnable to Run0 Participants
BotoxChange in Running Speed6 monthsSame or faster than before my injury7 Participants
BotoxChange in Running Speed6 monthsMinimally reduced0 Participants
BotoxChange in Running Speed6 monthsModerately reduced0 Participants
BotoxChange in Running Speed6 monthsSignificantly reduced0 Participants
BotoxChange in Running Speed6 monthsUnable to Run0 Participants
Secondary

Pain in the 24 Hours Following Running

A question on the UWRI asks the participant to indicate how much pain they experience during the 24 hours following a run: No pain, Minimal pain, Moderate pain, Significant pain, Unable to Run.

Time frame: baseline, 2 months, 4 months, 6 months

Population: One participant did not complete the 4 month survey

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
BotoxPain in the 24 Hours Following RunningbaselineNo Pain2 Participants
BotoxPain in the 24 Hours Following RunningbaselineMinimal Pain3 Participants
BotoxPain in the 24 Hours Following RunningbaselineModerate Pain1 Participants
BotoxPain in the 24 Hours Following RunningbaselineSignificant Pain0 Participants
BotoxPain in the 24 Hours Following RunningbaselineUnable to Run1 Participants
BotoxPain in the 24 Hours Following Running2 monthsNo Pain7 Participants
BotoxPain in the 24 Hours Following Running2 monthsMinimal Pain0 Participants
BotoxPain in the 24 Hours Following Running2 monthsModerate Pain0 Participants
BotoxPain in the 24 Hours Following Running2 monthsSignificant Pain0 Participants
BotoxPain in the 24 Hours Following Running2 monthsUnable to Run0 Participants
BotoxPain in the 24 Hours Following Running4 monthsNo Pain6 Participants
BotoxPain in the 24 Hours Following Running4 monthsMinimal Pain0 Participants
BotoxPain in the 24 Hours Following Running4 monthsModerate Pain0 Participants
BotoxPain in the 24 Hours Following Running4 monthsSignificant Pain0 Participants
BotoxPain in the 24 Hours Following Running4 monthsUnable to Run0 Participants
BotoxPain in the 24 Hours Following Running6 monthsNo Pain7 Participants
BotoxPain in the 24 Hours Following Running6 monthsMinimal Pain0 Participants
BotoxPain in the 24 Hours Following Running6 monthsModerate Pain0 Participants
BotoxPain in the 24 Hours Following Running6 monthsSignificant Pain0 Participants
BotoxPain in the 24 Hours Following Running6 monthsUnable to Run0 Participants
Secondary

Participant Confidence in Increasing the Duration and Intensity of Running

A question on the UWRI asks the participant to indicate how their injury affects their confidence to increase the duration or intensity of their running: Confident to increase my running, If I increase I might be fine, Neutral, If I increase I might get worse, I cannot increase my running.

Time frame: baseline, 2 months, 4 months, 6 months

Population: One participant did not complete the 4 month survey.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
BotoxParticipant Confidence in Increasing the Duration and Intensity of Running4 monthsI cannot increase my running0 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of RunningbaselineConfident to increase my running1 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of RunningbaselineIf I increase I might be fine0 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of RunningbaselineNeutral0 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of RunningbaselineIf I increase I might get worse3 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of RunningbaselineI cannot increase my running3 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of Running2 monthsConfident to increase my running5 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of Running2 monthsIf I increase I might be fine1 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of Running2 monthsNeutral1 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of Running2 monthsIf I increase I might get worse0 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of Running2 monthsI cannot increase my running0 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of Running4 monthsConfident to increase my running6 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of Running4 monthsIf I increase I might be fine0 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of Running4 monthsNeutral0 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of Running4 monthsIf I increase I might get worse0 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of Running6 monthsConfident to increase my running7 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of Running6 monthsIf I increase I might be fine0 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of Running6 monthsNeutral0 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of Running6 monthsIf I increase I might get worse0 Participants
BotoxParticipant Confidence in Increasing the Duration and Intensity of Running6 monthsI cannot increase my running0 Participants
Secondary

Participant Frustration With Injury

A question on the UWRI asks the participant to indicate how frustrated they are by their running injury: Not frustrated, Mildly frustrated, Moderately frustrated, Significantly frustrated, or Extremely frustrated.

Time frame: baseline, 2 months, 4 months, 6 months

Population: one participant did not answer 4 month survey

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
BotoxParticipant Frustration With InjurybaselineNot Frustrated0 Participants
BotoxParticipant Frustration With InjurybaselineMildly Frustrated1 Participants
BotoxParticipant Frustration With InjurybaselineModerately Frustrated1 Participants
BotoxParticipant Frustration With InjurybaselineSignificantly Frustrated1 Participants
BotoxParticipant Frustration With InjurybaselineExtremely Frustrated4 Participants
BotoxParticipant Frustration With Injury2 monthsNot Frustrated5 Participants
BotoxParticipant Frustration With Injury2 monthsMildly Frustrated2 Participants
BotoxParticipant Frustration With Injury2 monthsModerately Frustrated0 Participants
BotoxParticipant Frustration With Injury2 monthsSignificantly Frustrated0 Participants
BotoxParticipant Frustration With Injury2 monthsExtremely Frustrated0 Participants
BotoxParticipant Frustration With Injury4 monthsNot Frustrated5 Participants
BotoxParticipant Frustration With Injury4 monthsMildly Frustrated1 Participants
BotoxParticipant Frustration With Injury4 monthsModerately Frustrated0 Participants
BotoxParticipant Frustration With Injury4 monthsSignificantly Frustrated0 Participants
BotoxParticipant Frustration With Injury4 monthsExtremely Frustrated0 Participants
BotoxParticipant Frustration With Injury6 monthsNot Frustrated7 Participants
BotoxParticipant Frustration With Injury6 monthsMildly Frustrated0 Participants
BotoxParticipant Frustration With Injury6 monthsModerately Frustrated0 Participants
BotoxParticipant Frustration With Injury6 monthsSignificantly Frustrated0 Participants
BotoxParticipant Frustration With Injury6 monthsExtremely Frustrated0 Participants
Secondary

Participant Perception of Recovery From Injury

A question on the UWRI asks the participant to indicate how much recovery have they made from their running injury: Complete Recovery, Significant Recovery, Moderate Recovery, Minimal Recovery, No Recovery.

Time frame: baseline, 2 months, 4 months, 6 months

Population: One participant did not answer the 4 month survey.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
BotoxParticipant Perception of Recovery From InjurybaselineComplete Recovery0 Participants
BotoxParticipant Perception of Recovery From InjurybaselineSignificant Recovery0 Participants
BotoxParticipant Perception of Recovery From InjurybaselineModerate Recovery1 Participants
BotoxParticipant Perception of Recovery From InjurybaselineMinimal Recovery1 Participants
BotoxParticipant Perception of Recovery From InjurybaselineNo Recovery5 Participants
BotoxParticipant Perception of Recovery From Injury2 monthsComplete Recovery3 Participants
BotoxParticipant Perception of Recovery From Injury2 monthsSignificant Recovery4 Participants
BotoxParticipant Perception of Recovery From Injury2 monthsModerate Recovery0 Participants
BotoxParticipant Perception of Recovery From Injury2 monthsMinimal Recovery0 Participants
BotoxParticipant Perception of Recovery From Injury2 monthsNo Recovery0 Participants
BotoxParticipant Perception of Recovery From Injury4 monthsComplete Recovery5 Participants
BotoxParticipant Perception of Recovery From Injury4 monthsSignificant Recovery1 Participants
BotoxParticipant Perception of Recovery From Injury4 monthsModerate Recovery0 Participants
BotoxParticipant Perception of Recovery From Injury4 monthsMinimal Recovery0 Participants
BotoxParticipant Perception of Recovery From Injury4 monthsNo Recovery0 Participants
BotoxParticipant Perception of Recovery From Injury6 monthsComplete Recovery7 Participants
BotoxParticipant Perception of Recovery From Injury6 monthsSignificant Recovery0 Participants
BotoxParticipant Perception of Recovery From Injury6 monthsModerate Recovery0 Participants
BotoxParticipant Perception of Recovery From Injury6 monthsMinimal Recovery0 Participants
BotoxParticipant Perception of Recovery From Injury6 monthsNo Recovery0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026